BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1171247 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00521
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED TO MEDTRONIC FOR EVALUATION. FUNCTIONAL CHECK FOUND THAT BOTH DEVICES FUNCTIONED PROPERLY AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE SURGICAL PROCEDURE THE SURGEON COULD NOT LOCK THE HANDLES TO THE PAK NEEDLES AND CONVERTED TO AN OPEN PROCEDURE USING ANOTHER SYSTEM. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PAK NEEDLE LXH WARSAW ORTHOPEDIC INC. NA W08E1174

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other